Clinical Trial

Preoperative Stereotactic Radiotherapy for Treatment of Spinal Metastases

Study acronym: PRESTRASM
Recruiting
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Summary
The goal of this interventional clinical trial is to evaluate the efficacy and safety of preoperative hypofractionated Stereotactic Body Radiotherapy (SBRT) in the treatment of patients undergoing surgery for spinal metastases. The main questions this study aims to answer are: * Does preoperative SBRT result in local tumor control at the involved spinal segments as assessed by MRI/CT scan at 3 and 6 months postoperatively? * What are the postoperative outcomes in terms of pain intensity, functional status and quality of life? Participants will receive hypofractionated SBRT to spinal metastases shortly before surgical intervention. Participants will undergo preoperative and follow-up assessments, including: * MRI and CT scans before and after surgery and at 3 and 6 months after surgery to measure tumor size * Pain questionnaires where patients rate their current pain, worst pain, and average pain in the last 24 hours on a scale from 0 (no pain) to 10 (worst pain imaginable) * A short questionnaire (Karnofsky Performance Status) to assess the patient's general ability to carry out daily activities * Several patient questionnaires to evaluate back pain, physical limitations, and overall quality of life (Oswestry Disability Index, EORTC QLQ-C30, and EORTC QLQ-BM22)
Trial Details
NCT Number NCT07135817
Lead Sponsor University Medical Center Goettingen
Conditions Spinal Metastases, Solid Tumor Cancer
Enrollment 20 participants
Start Date 2025-08-01
Primary Completion 2026-11 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2025-08-22